da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND UMBILICAL HERNIA REPAIR ON (B)(6) 2007. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT UNDERWENT THE DA VINCI SURGICAL PROCEDURE WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS. PER THE MEDICAL RECORDS, THE PATIENT WAS STARTED ON LEVAQUIN ON POST-OP DAY 2 FOR POSSIBLE CELLULITIS. SHE HAD SLOW RETURN OF BOWEL FUNCTION. THE PATIENT WAS ONLY PASSING SMALL AMOUNTS OF GAS THROUGHOUT THE FIRST FEW DAYS OF HER HOSPITAL COURSE AND FELT VERY UNCOMFORTABLE GOING HOME. HER BOWEL REGIMEN WAS INITIATED ORALLY AND RECTALLY ON POST-OP DAY 4 AND BEGAN TO PASS GAS ON POST-OP DAY 5. SHE HAD A SMALL BOWEL MOVEMENT AND BY POST-OP DAY 6 FELT VERY COMFORTABLE GOING HOME. THE PATIENT WAS DISCHARGED ON (B)(6) 2007. ON (B)(6) 2008, THE PATIENT WAS SEEN IN AN ER FOR ABDOMINAL PAIN. THE PATIENT DID NOT HAVE ANY BOWEL MOVEMENTS

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A BJU INTERNATIONAL JOURNAL ARTICLE TITLED, PERIOPERATIVE AND RENAL FUNCTIONAL OUTCOMES OF ELECTIVE ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN) FOR RENAL TUMOURS WITH HIGH SURGICAL COMPLEXITY (VOLPE ET AL., 2014). THE JOURNAL ARTICLE NOTES SEVERAL OPERATIVE COMPLICATIONS. REFER TO MFR. REPORT 2955842-2015-00706 (PATIENT IDENTIFIER RC20155000211) WHICH WAS INITIALLY SUBMITTED TO THE FDA AND BEFORE THE SITE AND SURGEON NAMES RELATED TO THE SURGICAL PROCEDURES WERE KNOWN. ON 04/23/2015, A CORRESPONDENCE CONTACT FOR THE JOURNAL ARTICLE PROVIDED THE SITE AND SURGEON NAMES OF THE OPERATIVE COMPLICATIONS NOTED WITHIN THE JOURNAL ARTICLE. IN THE RESULTS SECTION OF THE BJUI JOURNAL ARTICLE, THE FOLLOWING IS STATED: IN ALL, 44 RAPNS FOR RENAL TUMOURS WITH PADUA SCORES OF > 10 WERE INCLUDED IN THE ANALYSIS; 23 TUMOURS (52.3%) WERE CT1B. THE MEDIAN (INTERQUARTILE RANGE; RANGE) OPERATIVE TIME, ESTIMATED BLOOD LOSS AND WARM ISCHAEMIA (WIT) WERE 120 (94, 132; 60-230) MIN, 150 (80, 200; 25- 1200) ML AND 16 (13.8, 18; 5-35) MIN, RESPECTIVELY. TWO INTRAOPERATIVE COMPLICATIONS OCCURRED (4.5%); ONE INFERIOR VENA CAVAL INJURY AND ONE BLEED FR

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT UNDERWENT ROBOTIC TECAB (TOTALLY ENDOSCOPIC CORONARY ARTERIES BYPASS) WITH 2 INTERNAL MAMMARY ARTERIES, USING THE DA VINIC S ROBOT AND COALESCENT "U" CLIPS TO FACILITATE DISTAL ANASTOMOSES, ON A BEATING HEART. ON CORONARY ANGIOGRAPHY 5 DAYS LATER, THERE WAS 80% STENOSIS OF ONE DISTAL ANASTOMOSIS, AND 40% STENOSIS OF ANOTHER.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTEMPTED TECAB (TOTALLY ENDOSCOPIC CORONARY ARTERY BYPASS) SURGERY USING THE DEVINIC S ROBOT AND FACULATED BY THE COALESENT U CLIP ON A BEATING HEART. ONLY 2 OUT OF 4 ARTERIES WERE BYPASSED. PT ARRESTED AT THE KIND OF THE PROCEDUSE. CPR WAS INITIATED AND THE CHEST OPENED . PT WAS CONNECTED TO CADIOPULOMONARY BYPASS AND ADDITIONAL BYPASS GRAFTS PERFORMED. PT DIED ON THE OPERATING ROOM TABLE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED IN (B)(4) THAT THE SIDE RAIL WAS DAMAGED ON WELDING.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AT THE END OF A DA VINCI HYSTERECTOMY SURGICAL PROCEDURE THE SURGICAL STAFF NOTICED A "DRIED OR BURN-LIKE" AREA AROUND THE CAMERA PORT INCISION, APPROX 2MM IN WIDTH. THE DAMAGED SKIN HAD TO BE CUFF OFF IN ORDER TO CLOSE THE INCISION. NO VISUAL DAMAGE NOR SIGNS OF MELTING WERE OBSERVED ON THE CANNULA ACCESSORY USED IN CONJUNCTION WITH THE CAMERA.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDWATCH UF/IMPORTER REPORT WAS REC'D AT ISI ON SEPTEMBER 28, 2007. INTUITIVE SURGICAL WAS PREVIOUSLY INFORMED OF THIS EVENT ON JULY 25, 2007. IT WAS ALSO REPORTED THAT THE PT WAS LATER BROUGHT BACK TO THE OR IN 2007, TO DRAIN CLOTS WHICH HAD FORMED, HOWEVER, THE DA VINCI SYS WAS NOT USED FOR THIS PROCEDURE. THE PT DIED FOUR DAYS POST DA VINCI ASSISTED SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 04/08/2010, ISI RECEIVED VOLUNTARY MEDWATCH (B)(4) FROM THE FDA DEPARTMENT OF HEALTH AND HUMAN SERVICES REPORTING THE FOLLOWING: VOLUN 01-FEB-2010: MY NAME IS (B)(6). I AM THE PERSONAL REP OF THE ESTATE OF (B)(6), ON (B)(6) 2007, MY MOTHER HAD A DAVINCI ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY AT (B)(6) MEDICAL CENTER IN (B)(6). IT IS MY UNDERSTANDING THAT DURING THIS EVENT, DR (B)(6) LOST VISUALIZATION AND THE INSTRUMENT ON THE ROBOT CUT THE RIGHT COMMON ILIAC ARTERY LEADING TO HEMORRHAGE, CARDIOPULONARY ARREST AND NEAR EXSAGUINATION. THE INFO I HAVE BEEN PROVIDED WITH INDICATES THAT THIS MAY HAVE BEEN REPORTED TO THE FDA AS A MAUDE ADVERSE EVENT ASSOCIATED WITH THE DAVINCI SURGICAL ROBOT. I HAVE NOT BEEN ABLE TO LOCATE SUCH A REPORT DURING MY ONLINE SEARCH. PHYSICIAN: (B)(6) MD. FACILITY: (B)(6) MEDICAL CENTER. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, INCLUDING INFORMATION RELATED TO THE FIELDS IN (B)(6).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON MARCH 12, 2010, ISI RECEIVED MAUDE EVENT REPORT (B) (4) WITH THE FOLLOWING EVENT DESCRIPTION: MY NAME IS XXX. I AM THE PERSONAL REP OF THE ESTATE OF XXX ON XX XX 2007, MY MOTHER HAS A DA VINCI ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY AT XXX MEDICAL CENTER IN XXX. IT IS MY UNDERSTANDING THAT DURING THIS EVENT DR XXX LOST VISUALIZATION AND THE INSTRUMENT ON THE ROBOT CUT THE RIGHT COMMON ILIAC ARTERY LEADING TO HEMORRHAGE, CARDIOPULMONARY ARREST AND NEAR EXSANGUINATION. THE INFO I HAVE BEEN PROVIDED WITH INDICATES THAT THIS MAY HAVE BEEN REPORTED TO THE FDA AS AN MAUDE ADVERSE EVENT ASSOCIATED WITH THE DA VINCI SURGICAL ROBOT. I HAVE NOT BEEN ABLE TO LOCATE SUCH A REPORT DURING MY ONLINE SEARCH. PHYSICIAN XXX. MEDICAL FACILITY XXX. NO ADDITIONAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON JUNE 10, 2008, INTUITIVE SURGICAL WAS NOTIFIED OF A PT DEATH PER LITIGATION DOCUMENTATION WHICH REPORTS THE FOLLOWING: IN 2007, FIVE DAYS AFTER UNDERGOING A DA VINCI RADICAL PROSTATECTOMY PROCEDURE, A PT UNDERWENT EMERGENCY EXPLORATORY LAPAROTOMY AND INTER ALIA. BOWEL NECROSIS WITH SEPTICEMIA WAS OBSERVED AND SAID TO BE THE RESULT OF AN INTEROPERATIVE MESENTERY TEAR. SIX CENTIMETERS OF CONTINUOUS STITCH WAS APPLIED TO REPAIR THE AFFECTED AREA, HOWEVER, THE PT EXPIRED.